The Recall Desk

FDA (Devices) recall action 76569

Repro-Med Systems, Inc. recalled 2 products on 2018-01-17

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-01-17
Critical
0
Units
—

Why these products were recalled

On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined t…

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2018-01-17

    Repro-Med HIgH-Flo Subcutaneous Safety Needle Sets Recalled for Packaging Defects

    Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.

    Product
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS3
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Distribution
    0 states
Repro-Med Systems, Inc. recalled 2 products on 2018-01-17 · The Recall Desk